Anti-Infectives, Sterile Injectables and Hospital Products Areas of Interest

Proposals should consider the impact of interventions on a variety of outcome categories, including but not limited to clinical outcomes, population outcomes, collateral damage (e.g., antimicrobial resistance, toxicity/adverse effects, selection of pathogenic organisms such as C. difficile), process measures, and costs. Proposals should consider that antimicrobials include antibiotics, antifungals, and antivirals. Proposals that include at least one of the following areas of interest, in no particular order, will be prioritized:

• Implementation science and behavioral science related to effectiveness of antimicrobial stewardship interventions, including applications of artificial intelligence approaches
• Outcomes associated with the following mechanisms to enhance antimicrobial stewardship:
  • Innovative digital tools, including applications of artificial intelligence tools
  • Rapid diagnostics, including applications of artificial intelligence tools
  • Patient engagement
  • Involvement of allied healthcare providers (e.g., nurses, microbiologists, community health workers, dentists, etc.)
• Antimicrobial stewardship interventions to support special patient populations (e.g., pediatrics, critically ill, hematology/oncology, Out-Patient Antimicrobial Therapy (OPAT), etc.)
• Antimicrobial stewardship interventions to reduce health disparities in infectious diseases management in resource-limited settings

Aztreonam-avibactam (ATM-AVI)

• In-vitro data generation for Multidrug Resistant Gram Negative Bacteria including Metallo-betalatamase (MBL) producing pathogens: 
  • Susceptibility (as compared to other Rx options and in c/o resistance to other treatment options) and molecular patterns- for Stenotrophomonas maltophilia and CR Enterobacterales in general and special population (immunocompromised, elderly, etc.)
  • Synergy studies for combination therapy for Enterobacterales, Stenotrophomonas maltophilia
  • Hollow fiber model studies for activity of ATM-AVI in MBL producing Stenotrophomonas maltophilia
• Pharmacokinetic/Pharmacodynamic (PK/PD) data in patient types as below:
  • With severe renal impairment on/not on renal replacement therapy including but not limited to CRRT
  • Tissue penetration data- e.g. lungs, meninges, skin and soft tissue, bone and joints (e.g. microdialysis methodology)
  • ECMO patients
  • With morbid obesity (BMI >/= 40)
• RWE on the clinical outcomes/Healthcare resource utilization with ATM-AVI
  • Impact of early diagnosis and treatment with ATM-AVI on clinical outcomes
  • Clinical effectiveness in diverse patient population including special population like immunocompromised patients- Cancer, Transplant, etc.

Ceftaroline fosamil

Research areas to be considered for support:

• Activity vs. resistant pathogens
• Prevalence of resistant gram + pathogens (e.g., penicillin NS (non-susceptible), macrolide resistant and/or ceftriaxone resistant Streptococcus pneumoniae)
• Monitor emergence of ceftaroline resistant strains: support local in vitro surveillance to supplement data

Ceftazidime-avibactam

Research areas to be considered for support:

• Microbiology and surveillance studies, invitro synergy studies with other antibiotics
• Clinical efficacy
• Tissue penetration
• Continuous infusion

Target populations:

• ICU patients
• Patients with comorbidities
• Patients with previous antibiotic exposure in <6 months
• Recent hospitalization

Out of scope:

• Patients with confirmed gram positive infections

Sulbactam-durlobactam (NOTE: Only proposals from China will be considered.)

Research areas to be considered for support:

• Microbiology and surveillance studies
• In vitro synergy studies with other antibiotics
• Epidemiology and treatment patterns
• Mortality and morbidity
• Pharmacoeconomics and LOS (length of stay)
• PK/PD data in special treatment modes or special patients
• Clinical research RWE on the clinical outcomes with SUL-DUR
• Impact on microbiota with SUL-DUR vs comparators

Isavuconazole

Research areas to be considered for support:

• Improve awareness of invasive mold infections
• Improve clinical diagnosis, new surrogate markers and diagnostic strategies, and improve mold infections laboratory capabilities
• Isavuconazole real-world data. Experience using isavuconazole, epidemiology of IFI and health disparity opportunities. Use in ECMO, renal and hepatic dysfunction, and switch from other azoles
• New uses for isavuconazole. prophylaxis, combination therapy, oral switch in candidiasis, in cryptococcus meningitis, and in chronic disease
• Disparity and equity. Vulnerable populations or/and neglected diseases as well as supporting minority mycologists in low-income countries

Target populations:

• Hematological malignancy
• Intensive care units
• Emerging patients at risk such with influenza, covid19 and new chemotherapies
• Chronic IFI disease and chronic pulmonary disease

Out of scope:

• Primary treatment of candidiasis
• Endemic mycoses: All studies in endemic mycoses (HIV and crypto after animal model, cocci animal model)

Invasive Fungal Infections Awareness and Diagnosis

Research areas to be considered for support:

• Improve awareness of invasive fungal infections (yeasts and molds)
• Improve clinical diagnosis, new surrogate markers and diagnostic strategies, and improve invasive fungal infections (yeasts and molds) laboratory capabilities
  • use of diagnostic tools, images or other techniques to enhance the knowledge in the early diagnosis of invasive fungal infections